REACCIONES ADVERSAS up to date

ATAZANAVIR:

Adverse Reactions Significant

Includes data from both treatment-naive and treatment-experienced patients. Percentages
listed for adults unless otherwise specified.
>10%:
Dermatologic: Skin rash (adults 3% to 21%; median onset: 7 weeks; children 14%)
Endocrine & metabolic: Increased serum cholesterol (240 mg/dL: 6% to 25%),
increased amylase (children: grades 3/4: 19%; adults: >2 times ULN: 14%)
Gastrointestinal: Nausea (3% to 14%)
Hepatic: Increased serum bilirubin (children: 3.2 mg/dL: 58%; adults: 2.6 times
ULN: 35% to 49%), jaundice (children 13% to 15%; adults 5% to 9%)
Neuromuscular & skeletal: Increased creatine phosphokinase (>5 times ULN: 6% to
11%)
Respiratory: Cough (children 21%)
Miscellaneous: Fever (children 18% to 19 %; adults 2%)
2% to 10%:
Cardiovascular: Peripheral edema (children 7%), first degree atrioventricular block
(6%), second degree atrioventricular block (children 2%; adults [rare])
Central nervous system: Headache (adults 1% to 6%; children 7% to 8%), peripheral
neuropathy (<1% to 4%), insomnia (<1% to 3%), depression (2%), dizziness
(<1% to 2%)
Endocrine & metabolic: Increased serum triglycerides (751 mg/dL: <1% to 8%),
hyperglycemia (251 mg/dL: 5%), hypoglycemia (children: grades 3/4: 4%)
Gastrointestinal: Vomiting (children 8% to 12%; adults 3% to 4%), diarrhea (children
8% to 9%; adults 1% to 3%), increased serum lipase (children: 2.6 times ULN:
5%; adults: >2 times ULN: <1% to 5%), abdominal pain (4%)

Hematologic & oncologic: Neutropenia (grades 3/4: children 9% to 12%; adults 3% to

7%), decreased hemoglobin (adults: <8.0 g/dL:<1% to 5%; children: grades 3/4:
3%), thrombocytopenia (grades 3/4: 2%)
Hepatic: Increased serum ALT (adults: >5 times ULN: 3% to 9%; 10% to 25% in
patients seropositive for hepatitis B and/or C; children: grades 3/4: 5%), increased
serum AST (>5 times ULN: 2% to 7%; 9% to 10% in patients seropositive for
hepatitis B and/or C)
Neuromuscular & skeletal: Myalgia (4%), limb pain (children 6%)
<2% (Limited to important or life-threatening): Cholecystitis, cholelithiasis, cholestasis,
complete atrioventricular block (rare), diabetes mellitus, DRESS syndrome, edema,
erythema multiforme, immune reconstitution syndrome, interstitial nephritis, left
bundle branch block, maculopapular rash, nephrolithiasis, pancreatitis, prolongation PR interval on ECG, prolonged Q-T interval on ECG, Stevens-Johnson syndrome,
torsades de pointe

ZIDOVUDINA

Adverse Reactions Significant

Note: Percentages noted with adults unless otherwise stated.
>10%:
Central nervous system: Headache (63%), malaise (53%), fever (children 25%)
Dermatologic: Rash (children 12%)
Gastrointestinal: Nausea (adults 51%; children 8%), anorexia (20%), vomiting (adults
17%; children 8%)
Hematologic: Macrocytosis (children >50%), anemia (neonates 22%; children 4%;
adults 1%; onset 2-4 weeks)
Hepatic: Hepatomegaly (children 11%)
Respiratory: Cough (children 15%)
1% to 10%:

Cardiovascular: ECG abnormality (children <6%), edema (children <6%), heart failure
(children <6%), left ventricular dilation (children <6%)
Central nervous system: Irritability (children <6%), nervousness (children <6%), chills
(5%), fatigue (5%), insomnia (5%)
Gastrointestinal: Diarrhea (children 8%), constipation (6%), weight loss (children
<6%), abdominal cramps (5%), abdominal pain (5%), dyspepsia (5%)
Genitourinary: Hematuria (children <6%)
Hematologic: Neutropenia (children 8%), granulocytopenia (2%; onset 6-8 weeks),
thrombocytopenia (children 1%)
Hepatic: Transaminases increased (1% to 3%)
Neuromuscular & skeletal: Weakness (9%), arthralgia (5%), musculoskeletal pain
(5%), myalgia (5%), neuropathy (5%)
Otic: Discharge/erythema/pain/swelling (7%)

TENOFOVIR:

Adverse Reactions Significant

Includes data from both treatment-naive and treatment-experienced HIV patients and in
chronic hepatitis B.
>10%:
Central nervous system: Insomnia (3% to 18%), headache (5% to 14%), pain (12% to
13%), dizziness (8% to 13%), depression (4% to 11%)
Dermatologic: Skin rash (includes maculopapular, pustular, or vesiculobullous rash;
pruritus; or urticaria: 5% to 18%), pruritus (16%)
Endocrine & metabolic: Hypercholesterolemia (19% to 22%), increased serum
triglycerides (1% to 4%)
Gastrointestinal: Abdominal pain (4% to 22%), nausea (8% to 20%), diarrhea (9% to
16%), vomiting (2% to 13%)

Neuromuscular & skeletal: Decreased bone mineral density (28%; 5% at spine or

7% at hip), increased creatine phosphokinase (2% to 12%), weakness (6% to
11%)
Miscellaneous: Fever (4% to 11%)
1% to 10%:
Cardiovascular: Chest pain (3%)
Central nervous system: Fatigue (9%), anxiety (6%), peripheral neuropathy (1% to
5%)
Dermatologic: Diaphoresis (3%)
Endocrine & metabolic: Weight loss (2% to 4%), glycosuria (grades 3/4: 3%),
hyperglycemia (grades 3/4: 2% to 3%), lipodystrophy (1%)
Gastrointestinal: Increased serum amylase (grades 3/4: 4% to 9%), anorexia (3% to
4%), dyspepsia (3% to 4%), flatulence (3% to 4%)
Genitourinary: Hematuria (grades 3/4: 3% to 7%)
Hematologic & oncologic: Neutropenia (3%)
Hepatic: Increased serum ALT (2% to 10%), increased serum AST (3% to 5%),
increased serum transaminases (2% to 5%), increased serum alkaline phosphatase
(1%)
Neuromuscular & skeletal: Back pain (4% to 9%), arthralgia (5%), myalgia (4%)
Renal: Increased serum creatinine (9%), renal failure (7%)
Respiratory: Sinusitis (8%), upper respiratory tract infection (8%), nasopharyngitis
(5%), pneumonia (2% to 5%)

ESTAVUDINA:

Adverse ReactionsSignificant

Adverse reactions reported below represent experience with combination therapy with other
nucleoside analogues and protease inhibitors.
>10%:
Central nervous system: Headache (25% to 46%)
Dermatologic: Rash (18% to 30%)
Gastrointestinal: Nausea (43% to 53%; less than comparator group), vomiting (18% to
30%; less than comparator group), diarrhea (34% to 45%)
Hepatic: Hyperbilirubinemia (65% to 68%; grade 3/4: 7% to 16%), AST increased
(42% to 53%; grade 3/4: 5% to 7%), ALT increased (40% to 50%; grade 3/4: 6%
to 8%), GGT increased (15% to 28%; grade 3/4: 2% to 5%)
Neuromuscular & skeletal: Peripheral neuropathy (8% to 21%)
Miscellaneous: Amylase increased (21% to 31%; grade 3/4: 4% to 8%), lipase
increased (~27%; grade 3/4: 5% to 6%)

LAMIVUDINA

Adverse Reactions Significant

Incidence data include patients on combination therapy with other antiretroviral agents.
>10%:
Central nervous system: Headache (21% to 35%), fatigue (24% to 27%), insomnia
(11%)
Gastrointestinal: Nausea (15% to 33%), diarrhea (14% to 18%), pancreatitis (range:
0.3% to 18%; higher percentage in pediatric patients), abdominal pain (9% to
16%), vomiting (13% to 15%)
Hematologic: Neutropenia (7% to 15%)
Hepatic: Transaminases increased (2% to 11%)
Neuromuscular & skeletal: Myalgia (8% to 14%), neuropathy (12%), musculoskeletal
pain (12%)

Respiratory: Nasal signs and symptoms (20%), cough (18%), sore throat (13%)
Miscellaneous: Infections (25%; includes ear, nose, and throat)
1% to 10%:
Central nervous system: Dizziness (10%), depression (9%), fever (7% to 10%), chills
(7% to 10%)
Dermatologic: Rash (5% to 9%)
Gastrointestinal: Anorexia (10%), lipase increased (10%), abdominal cramps (6%),
dyspepsia (5%), amylase increased (<1% to 4%), heartburn
Hematologic: Thrombocytopenia (1% to 4%), hemoglobinemia (2% to 3%)
Neuromuscular & skeletal: Creatine phosphokinase increased (9%), arthralgia (5% to
7%)
<1% (Limited to important or life-threatening): Alopecia, anaphylaxis, anemia, body fat
redistribution, hepatitis B exacerbation, hepatomegaly, hyperbilirubinemia,
hyperglycemia, immune reconstitution syndrome, lactic acidosis, lymphadenopathy,
muscle weakness, paresthesia, peripheral neuropathy, pruritus, red cell aplasia,
rhabdomyolysis, splenomegaly, steatosis, stomatitis, urticaria, weakness, wheezing

LINEZOLID:

Adverse Reactions Significant

Percentages as reported in adults; frequency similar in pediatric patients unless otherwise
noted.
>10%:
Central nervous system: Headache (<1% to 11%)
Gastrointestinal: Diarrhea (3% to 11%)
Hematologic & oncologic: Decreased hemoglobin (1% to 16%), thrombocytopenia
(<1% to 13%), leukopenia (children 1% to 12%; adults <1% to 2%)
1% to 10%:
Central nervous system: Insomnia (3%), dizziness (3%), vertigo (children 1%)

Dermatologic: Skin rash (1% to 2%), pruritus (children 1%)

Endocrine & metabolic: Increased amylase (<1% to 2%), increased lactate
dehydrogenase (<1% to 2%)
Gastrointestinal: Nausea (1% to 10%), vomiting (1% to 9%), increased serum lipase
(3% to 4%), constipation (2%), dysgeusia (1% to 2%), loose stools (children 1%
to 2%), oral candidiasis (1% to 2%), abdominal pain (2%), tongue discoloration
(1%), pancreatitis
Genitourinary: Vulvovaginal candidiasis (1% to 2%)
Hematologic & oncologic: Neutropenia (children 1% to 6%; adults 1%), anemia
(children 6%; adults 2%), eosinophilia (children 2%)
Hepatic: Increased serum ALT (10%), increased serum bilirubin (children 6%;
adults 1%), increased serum AST (adults 2% to 5%), increased serum alkaline
phosphatase (<1% to 4%), abnormal hepatic function tests (2%)
Infection: Fungal infection (1% to 2%)
Renal: Increased blood urea nitrogen (2%), increased serum creatinine (<1% to 2%)
Miscellaneous: Fever (2%)
<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, bullous skin
disease, Clostridium difficile-associated diarrhea, convulsions, hypertension,
hypoglycemia, lactic acidosis, optic neuropathy, pancytopenia, peripheral neuropathy,
rhabdomyolysis, seizures, serotonin syndrome (with concurrent use of other
serotonergic agents), Stevens-Johnson syndrome, vision loss

GANCICLOVIR:

Adverse Reactions Significant

>10%:
Central nervous system: Fever (48%)
Gastrointestinal: Diarrhea (44%), anorexia (14%), vomiting (13%)

Hematologic: Thrombocytopenia (57%), leukopenia (41%), anemia (16% to 26%),

neutropenia with ANC <500/mm3 (12% to 14%)
Ocular: Retinal detachment (11%; relationship to ganciclovir not established)
Renal: Serum creatinine increased (2% to 14%)
Miscellaneous: Sepsis (15%), diaphoresis (12%)
1% to 10%:
Central nervous system: Chills (10%), neuropathy (9%)
Dermatologic: Pruritus (5%)
<1% (Limited to important or life-threatening): Allergic reaction (including anaphylaxis),
alopecia, arrhythmia, bronchospasm, cardiac arrest, cataracts, cholestasis, coma,
dyspnea, edema, encephalopathy, exfoliative dermatitis, extrapyramidal symptoms,
hepatitis, hepatic failure, pancreatitis, pancytopenia, pulmonary fibrosis, psychosis,
rhabdomyolysis, seizure, alopecia, urticaria, eosinophilia, hemorrhage, StevensJohnson syndrome, torsade de pointes, renal failure, SIADH, visual loss